DDT-COA-000-163 Accelerating the FDA COA Qualification Plan for the PSYCHS as a ClinRO measure

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Abstract The clinical high-risk syndrome for psychosis (CHR-P) is a common psychiatric condition identified in the American Psychiatric Association’s Diagnostic and Statistical Manual (DSM-5). CHR-P primarily affects youth and young adults who exhibit multiple symptoms, including attenuated positive symptoms (delusions and hallucinations) that are distressing and impairing of daily activities. Clinical trials are urgently needed to develop specific and safe treatments for attenuated positive symptoms in CHR-P patients. An obstacle to the design and funding of these needed trials, however, is the absence of an FDA-qualified clinical outcome measure for use as the primary outcome upon which efficacy is assessed. A new instrument to measure the severity of attenuated positive symptoms, called the PSYCHS, has been recently developed as part of Foundation for the National Institutes of Health-funded Accelerating Medicines Partnership Schizophrenia observational study. The study is designed to prepare for future clinical trials supporting drug registration in CHR-P. The PSYCHS harmonizes two existing instruments extensively used in the field. A letter of intent to pursue qualification of the PSYCHS has been deemed reviewable by the FDA. The next step is to develop a Qualification Plan. The objective of the current application is to develop a comprehensive and robust clinical assessment outcome Qualification Plan for the PSYCHS. The current project will accelerate development of the Qualification Plan by: a) obtaining FDA input through a series of teleconferences and meetings; b) engaging academic experts, patients, and analytic resources to systematize current evidence supporting the conceptual suitability of the PSYCHS; and c) conduct preliminary qualitative studies to help develop the content validity section of the Qualification Plan.